Anastomotic Device for Large Vascular Grafts
Small Business Information
ABIOMED, INC., 22 CHERRY HILL DRIVE, DANVERS, MA, 01923
AbstractDESCRIPTION (provided by applicant): The objective of this proposed program is to develop a general purpose anastomotic device for large vessels and vascular grafts, based on a novel stapler design. The use of the device can provide an alternative procedur e to the current manual suturing methods, with the potential of yielding anastomoses having better and more reproducible performance, and with reduced cross-clamping or bypass time requirements. The immediate application of this device is in making an end- to-side anastomosis between a graft/cannula and the aorta, for example, as the outflow conduit for a VAD. Under Phase I of the program, a feasibility prototype will be designed, fabricated, and characterized via both ex vivo and acute in vivo studies. Base d upon the success of our Phase I studies, Phase II of the program would focus on the development of a tool with integrated functions, chronic in vivo studies for biocompatibility, and design optimization for ease of use and manufacturing. PUBLIC HEALTH RE LEVANCE: The stapler will improve the quality of large vascular anastomoses and reduce the operating time requirements. There are numerous surgical applications that could benefit from a rapid and repeatable method of placing large (i.e. greater than 5 mm diameter) synthetic vascular grafts, especially a method that reduces the rate of bleeding complications. These include ventricular assist device (VAD) implantation, arteriovenous (AV) fistula placement for renal dialysis, aortic arch reconstruction, and a bdominal aortic aneurysm (AAA) repair. This vascular stapler may be applicable to 100,000 procedures per year in the U.S. alone.
* information listed above is at the time of submission.